Dr. Reddy’s Laboratories announces the launch of Febuxostat Tablets in the U.S. Market n3m19

Dr. Reddy's Laboratories announces the launch of Febuxostat Tablets in the U.S. Market

Hyderabad, India and Princeton, NJ, USA –  Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s” today announced the launch of Febuxostat Tablets, a therapeutic equivalent generic version of Uloric (Febuxostat) Tablets approved by the U.S. Food and Drug istration (USFDA).

The Uloric brand and generic had U.S. sales of approximately $108 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health*.

Dr. Reddy’s Febuxostat Tablets are available in 40 mg and 80 mg strengths in bottle count sizes of 30 tablets.

Please see the full prescribing information including boxed warning.

https://www.drreddys.com/pi/febuxostat_tablets.pdf

WARNING: CARDIOVASCULAR DEATH

Gout patients with established cardiovascular (CV) disease treated with Febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)].

Consider the risks and benefits of Febuxostat when deciding to prescribe or continue patients on Febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1)].

Uloric is a trademark of TEIJIN KABUSHIKI KAISHA (TEIJIN LIMITED)

*IQVIA Retail and Non-Retail MAT October 2020.

RDY-0121-323